Could you inform us about the advance of the specifications and testing protocols to ensure the performance, quality and safety of ultra-low temperature (ULT).
Very interesting discussion and some important points made.
Over the last year, WHO and UNICEF offices at all levels have been communicating intensively with member states about cold chain and ultra-cold chain (UCC) equipment deployment to support possible COVID-19 vaccine introduction. While the logistical challenges of doing so in LMIC settings are clear, experience with deploying the Ebola vaccine has proved that it is not impossible. WHO and UNICEF continue to be to provide countries with the necessary tools and guidance to make the correct decisions to support their immunization needs and goals. Related to this, members be interested in the following ISC resources and guidance, some recently shared on TechNet-21:
COVID-19 Vaccination, Country Readiness and Delivery: Supply and Logistics Guidance (working copy)
"The COVAX Supply and Logistics workstream, led by UNICEF, Gavi and WHO, have released a working copy of the COVID-19 Vaccination, Country Readiness & Delivery: Supply and Logistics Guidance. Countries might find this Guide useful when developing and strengthening their supply chain strategies to receive, store, distribute and manage the COVID-19 vaccines and their ancillary products, in line with their national deployment and vaccination plan (NDVP). The document also provides links to the different tools and resources to aid countries in performing assessment, planning and capacity-building activities."
COVID-19 Vaccine Introduction Readiness Assessment Tool (VIRAT/VRAF 2.0) - Version 3 December 2020
This Readiness Assessment tool is a national level tool. Data inputs should be entered into the worksheet 'National Readiness'. Suggestions for timing and intervals to implement activities and assess progress are provided in the timeline. Pre-planning activities should be initiated as early as Sept 2020 (earliest time interval provided) as COVID-19 vaccines may be available for introduction by early 2021. The tool will be updated as soon as more certainty about global vaccine supply availability becomes available. DRAFT DOCUMENT, PENDING PUBLICATION ON THE WHO WEBSITE.
Article from the November edition of the Global Immunization Newsletter (GIN) “COVID-19 vaccine deployment using ultra-cold chain system”
Attached for reference.
Other WHO immunization-specific guidance relating to COVID-19
Listed here: https://www.technet-21.org/en/topics/covid-19
Other supply chain tools from WHO HQ of use to countries
Attached for reference.
I am glad you have raised this topic and have also been alarmed that we are not hearing more about these issues. As you say, there must be more focus on how countries will use the available vaccine products to vaccinate their populations. The focus up to now has been all about the development, manufacture and supply of the vaccines themselves. The characteristics of competing vaccine products which fit best into country immunization programs have received insufficient attention by partners, even for traditional and familiar vaccines.
For far too long, decades really, the focus in the area of cold chain has generally been on equipment and less on supply chain management, handling and transport of vaccines. The requirements for Covid vaccination will unfortunately expose pre-existing under-investment and weaknesses in logistics, which must now be identified and ameliorated to the extent possible.
I hope that UNICEF, Gavi and WHO are racing to guide countries on how to determine the most suitable COVID vaccine product for their particular contexts. (This may not be comfortable territory for these agencies, especially given past reluctance to over-segment vaccine markets.) International partners have an essential role now in providing basic information and technical support to inform high-level political and technical bodies at country level, so that appropriate decisions are made whenever vaccine products are offered to them -- and so they can forecast product-specific needs better on the global stage. And within countries, the MOHs and international partners should do what they can, more so than in the past, to ensure that the voices of logisticians are also heard as vaccine product choices are being discussed and delivery strategies formulated.
Guidance is needed comparing the vaccine products on so many topics, such as storage temperatures, dosage, number of doses required per individual, whether dilution is required, number of doses within a vial and number of doses per secondary package (some vaccines will be in trays of nearly 1000 doses, which is great for international transport but difficult to be broken down and used at local levels within cold storage and use constraints), how soon some vaccines must be used after reconstitution, how soon vaccines must be used after removal from ultra-cold freezers (e.g., I believe that after thawing, the undiluted Pfizer vaccine can only stay in a refrigerator for 5 days), etc. In addition to your observations, it is time immediately to start planning for the safe collection and destruction of used medical sharps to avoid transmission of blood-borne disease since in resource-poor countries, disposable items sometimes get re-used. And how will leakage of vaccines to a “black market” be prevented? How will counterfeit vaccines be detected and avoided?
These are all operational issues which must receive urgent attention now. If necessary NITAGs should supplement their membership with individuals well-versed in operational and programmatic issues of this nature.
I very much support the issue raised by Larry and Rafael. It is not clear why WHO HQ and the Regional offices appear unwilling to issue guidance and recommendations to its LMIC member states that the technical complexity, technical resources and costs associated with ULT refrigeration make it an inappropriate choice for nationwide vaccine roll-out in most LMICs. The reasons are self-evident -- the lack of technical HR, the difficulty in procuring and installing equipment, uninterrupted power supplies, dry ice manufacture, poor transport infrastructure, advanced HCW training, cost, and more. There may be some confusion on the part of some or our colleagues between giving countries sound technical advice based on solid field experience and offending countries by implying that they are not competent or that this represents an unacceptable inequity in treatment.
Some colleagues argue that DRC and other African countries showed they could handle ebola vaccine in ULT refrigeration. But this ignores the reality that these operations were small by comparison, closely monitored by WHO and partners, and cost a fortune.
We do not recommend a lot of high-tech innovations in limited resource settings, so why not be transparent and explain in detail why this is simply a non-starter for most LMICs. Imagine what would happen if scarce vaccine were wasted through improper handling in an LMIC lacking adequate infrastructure?
I believe we are failing in our responsibilities if we do not speak up quickly and manage expectations before resources are wasted.
I trust that supply chain exerts and logisticians will add their voice.
I like to share some constraints about of ULT equipments vs ILR.
1. Cost: USD 28.000 in Colombia to ULT vs USD 2.500 in Colombia to ILR, prices with taxes, that means a ratio of 11,2:1
2. Weight: 271 Kg. to ULT vs 100 Kg. to ILR, 2,71:1
3. Energy consumption, stable running: 17,5 KWh/24h to ULT vs 0.62 KWh/24h to ILR. 28,2:1.
4. Maintenance service: to ULT lack of expert technicians vs enough and easier maintenance to ILR.
5. The high quality of the energy for ULT is crucial and these does not ever is achieved in all the countries and rural zones.
Furthermore, the time required to produce ULT equipments is longer than ILR and the time is very limited. No one vaccination campaign has been carried out in less than six months. Look at seasonal influenza and measles with very little population compared to this COVID 19 goal.
CO2 to put inside of cold boxes and vaccine carriers is very expensive and its production is very limited or nule. Focusing all the effort on this frozen vaccine against COVID 19 reduces the coverage of the rest of the vaccination scheme.
The longer the vaccine takes to become available, the more people will not get vaccinated.
For vaccines requiring ultra-low storage temperatures (i.e. ≤60°C), WHO PQS is in the process of developing a range of performance specifications and testing protocols to ensure the performance, quality and safety of ultra-low temperature (ULT) CCE. Building on lessons learned from the Ebola vaccine, WHO PQS wants to make sure that ULT CCE takes into account the needs and challenges immunization programs face when it comes to transportation, storage, management and handling of ULT vaccines.
Right now, WHO PQS performance specifications for both active (freezers) and passive (cold boxes) ULT appliances are under development with the support of industry and non-industry partners. Dedicated specifications for ULT power systems are also being developed to ensure a continuous power supply to ULT appliances. The same goes for ULT accumulators for use in passive ULT devices. Our objective is to publish these ULT performance specifications and testing protocols in December 2020. Specifications for ULT temperature monitoring devices will follow in the new year.
In addition to ULT CCE availability, a discussion is also needed on how we will prepare our health care professionals to safely manage and handle ULT CCE. EPI Standard Operating Procedures and guidelines need to developed concurrently to ensure the safe distribution of ULT vaccines.
Isaac GOBINA, WHO PQS Secretariat
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